Type 2 Diabetes Clinical Trial
— AWARD-7Official title:
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
| Status | Completed |
| Enrollment | 577 |
| Est. completion date | December 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men and non-pregnant women aged =18 years - Hemoglobin A1c (HbA1c) =7.5% and =10.5% - Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication - Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of =15 to <60 milliliters per minute (mL/min)/1.73 meter squared (m^2) - Able and willing to perform multiple daily injections - Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m^2) Exclusion Criteria: - Stage 5 CKD as defined by eGFR <15 mL/min/1.73 m^2 OR having required dialysis - Rapidly progressing renal dysfunction likely to require renal replacement - History of a transplanted organ - Type 1 diabetes mellitus - At screening a systolic blood pressure of =150 mmHg or a diastolic blood pressure of =90 mmHg with or without antihypertensive medication - An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit - Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke) - Acute or chronic hepatitis - Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis - Serum calcitonin =35 picograms per milliliter (pg/mL) at Screening Visit - Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma - Known history of untreated proliferative retinopathy |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Belem | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Curitiba | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Juiz De Fora | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Passo Fundo | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Porto Alegre | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Catarina | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São Paulo | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baja | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Esztergom | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaposvar | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kecskemet | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pecs | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Satoraljaujhely | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Siofok | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chihuahua | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Culiacan | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guadalajara | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gdansk | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lodz | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szczecin | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zgierz | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bacau | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Deva | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oradea | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Targu Mures | |
| Romania | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Timisoara | |
| South Africa | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cape Town | |
| South Africa | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Durban | |
| South Africa | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johannesburg | |
| South Africa | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Somerset West | |
| South Africa | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Worcester | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | |
| Ukraine | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dnipropetrovsk | |
| Ukraine | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyiv | |
| Ukraine | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lugansk | |
| Ukraine | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poltava | |
| Ukraine | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ternopil | |
| United States | Endocrine Group, LLP | Albany | New York |
| United States | Center For Clinical Research | Austin | Texas |
| United States | North American Research Institute | Azusa | California |
| United States | Erie County Medical Center State University | Buffalo | New York |
| United States | Boise Kidney & Hypertension Institute | Caldwell | Idaho |
| United States | Southeast Renal Research Institute | Chattanooga | Tennessee |
| United States | Carolina Clinical Trials LLC | Concord | North Carolina |
| United States | Endocrine Associates of Dallas | Dallas | Texas |
| United States | Office of Dr. Sergio Rovner | El Paso | Texas |
| United States | Renal Consultants Medical Group | Granada Hills | California |
| United States | Marin Endocrine Associates | Greenbrae | California |
| United States | Physicians East | Greenville | North Carolina |
| United States | The Center for Diabetes & Endocrine Care | Hollywood | Florida |
| United States | University of Hawaii Clinical Research | Honolulu | Hawaii |
| United States | Endocrine Associates, LLC | Houston | Texas |
| United States | Juno Research | Houston | Texas |
| United States | The Endocrine Center | Houston | Texas |
| United States | East Coast Clinical Research | Jacksonville | Florida |
| United States | Knoxville Kidney Center, PLLC | Knoxville | Tennessee |
| United States | Nebraska Nephrology Research Institute, LLC | Lincoln | Nebraska |
| United States | Academic Medical Research Institute | Los Angeles | California |
| United States | Pacific Renal Research Institute | Meridian | Idaho |
| United States | Avanced Medical and Pain Mangement Research Clinic (AMPM) | Miami | Florida |
| United States | Baptist Diabetes Association | Miami | Florida |
| United States | Pharmax Research Clinic | Miami | Florida |
| United States | San Marcus Research Clinic, Inc. | Miami | Florida |
| United States | Ocean Blue Medical Research Center, Inc. | Miami Springs | Florida |
| United States | Sutter Gould Medical Foundation | Modesto | California |
| United States | Extended Arm Physician, Inc. | Montgomery | Alabama |
| United States | Diabetes & Endocrinology Consultants PC | Morehead City | North Carolina |
| United States | Suncoast Clinical Research | New Port Richey | Florida |
| United States | Discovery Medical Research Group | Ocala | Florida |
| United States | South Carolina Nephrology and Hypertension Center, Inc. | Orangeburg | South Carolina |
| United States | Suncoast Clinical Research | Palm Harbor | Florida |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Partners in Nephrology & Endocrinology | Pittsburgh | Pennsylvania |
| United States | Penobscot Bay Medical Center | Rockport | Maine |
| United States | Boice Willis Clinic, PA | Rocky Mount | North Carolina |
| United States | Institute for clinical studies | Rosedale | New York |
| United States | San Antonio Kidney Disease Center Physicians Group | San Antonio | Texas |
| United States | Endocrine Associates of Long Island, PC | Smithtown | New York |
| United States | Providence Health & Services | Spokane | Washington |
| United States | Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist | Sumter | South Carolina |
| United States | Cotton O'Neil Clinic | Topeka | Kansas |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Infosphere | West Hills | California |
| United States | Univ of Kansas Schl of Medicine , Wichita | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Brazil, Hungary, Mexico, Poland, Romania, South Africa, Spain, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | Baseline, 26 Weeks | |
| Secondary | Percentage of Participants Whose HbA1c Was <7.0% | Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). | 26 Weeks | |
| Secondary | Percentage of Participants Whose HbA1c Was <8.0% | Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). | 26 Weeks | |
| Secondary | Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) | The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Fasting Glucose (FG) | LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Mean Daily Insulin Lispro Dose | The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | Baseline, 26 Weeks | |
| Secondary | Percentage of Participants With Estimated Average Glucose <154 mg/dL | Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). | 26 Weeks | |
| Secondary | Change From Baseline in Serum Creatinine (sCr) | Change from baseline in serum creatinine (sCr) levels after treatment. | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Estimated Creatinine Clearance (eCrCl) | Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) | The change from baseline in Urinary Albumin to Creatinine Ratio (UACR). | Baseline, 26 Weeks | |
| Secondary | Change From Baseline in Body Weight | LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. • |
Baseline, 26 Weeks | |
| Secondary | Percentage of Participants With Self-Reported Hypoglycemic Events (HE) | Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =3.9 mmol/L (=70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 26 Weeks | |
| Secondary | Rate of Hypoglycemic Events | Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 26 Weeks | |
| Secondary | Change From Baseline in HbA1c | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | Baseline, 52 Weeks | |
| Secondary | Percentage of Participants Whose HbA1c is <7.0% | Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). | 52 Weeks | |
| Secondary | Percentage of Participants Whose HbA1c is <8.0% | Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). | 52 Weeks | |
| Secondary | Change From Baseline in 8-Point SMPG | The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). | Baseline, 52 Weeks | |
| Secondary | Change From Baseline in FG | LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured | Baseline, 52 Weeks | |
| Secondary | Change in Mean Daily Insulin Lispro Dose | The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | Baseline, 52 Weeks | |
| Secondary | Percentage of Participants With Estimated Average Glucose <154 mg/dL | Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). | 52 Weeks | |
| Secondary | Change From Baseline in sCr | Change from baseline in sCr levels after treatment. | Baseline, 52 Weeks | |
| Secondary | Change From Baseline in eGFR | The change in eGFR by using CKD-EPI equation. | Baseline, 52 Weeks | |
| Secondary | Change From Baseline in eCrCl | eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. | Baseline, 52 Weeks | |
| Secondary | Change From Baseline in UACR | The change from baseline in UACR | Baseline, 52 Weeks | |
| Secondary | Change From Baseline in Body Weight | LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. | Baseline, 52 Weeks | |
| Secondary | Percentage of Participants With Self-Reported Hypoglycemic Events (HE) | Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =3.9 mmol/L (=70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 52 Weeks | |
| Secondary | Rate of Hypoglycemic Events (HE) | HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 52 Weeks | |
| Secondary | Participants With Events of Allergic/Hypersensitivity Reactions | Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ | Baseline through 52 Weeks |
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